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Last Updated: May 20, 2022

LAMOTRIGINE Drug Patent Profile


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Which patents cover Lamotrigine, and what generic alternatives are available?

Lamotrigine is a drug marketed by Actavis Elizabeth, Amneal Pharms, Anchen Pharms, Atlantide, Dr Reddys Labs Ltd, Par Pharm, Rubicon, Torrent, Yiling, Zydus Pharms, Alembic Pharms Ltd, Aurobindo Pharma, Glenmark Pharms Ltd, Jubilant Generics, Mylan, Sandoz, Taro, Teva, Watson Labs, Zydus Pharms Usa Inc, Ajanta Pharma Ltd, Amring Pharms, Impax Labs Inc, Sciegen Pharms Inc, Actavis Totowa, Alkem Labs Ltd, Cipla, Glenmark Generics, Granules, Hikma Pharms, Jubilant Cadista, Lupin Ltd, Mylan Labs Ltd, Rising, Roxane, Taro Pharm Inds, Torrent Pharms, Unichem Labs Ltd, Zennova, and Zydus Pharms Usa. and is included in forty-nine NDAs.

The generic ingredient in LAMOTRIGINE is lamotrigine. There are thirty-two drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Lamotrigine

A generic version of LAMOTRIGINE was approved as lamotrigine by DR REDDYS LABS LTD on January 22nd, 2009.

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Drug patent expirations by year for LAMOTRIGINE
Drug Prices for LAMOTRIGINE

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Drug Sales Revenue Trends for LAMOTRIGINE

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Recent Clinical Trials for LAMOTRIGINE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Brown UniversityPhase 2
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Phase 2
Postgraduate Institute of Dental Sciences RohtakPhase 4

See all LAMOTRIGINE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for LAMOTRIGINE
Paragraph IV (Patent) Challenges for LAMOTRIGINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LAMICTAL XR Extended-release Tablets lamotrigine 25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg 022115 1 2014-02-12
LAMICTAL ODT Orally Disintegrating Tablets lamotrigine 25 mg, 50 mg, 100 mg, and 200 mg 022251 1 2009-12-21

US Patents and Regulatory Information for LAMOTRIGINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva LAMOTRIGINE lamotrigine TABLET, FOR SUSPENSION;ORAL 076420-001 Jun 21, 2006 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Actavis Totowa LAMOTRIGINE lamotrigine TABLET;ORAL 078669-003 Apr 8, 2011 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Torrent LAMOTRIGINE lamotrigine TABLET, EXTENDED RELEASE;ORAL 203370-002 Dec 23, 2013 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Par Pharm LAMOTRIGINE lamotrigine TABLET, EXTENDED RELEASE;ORAL 201791-003 Jan 18, 2013 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Taro Pharm Inds LAMOTRIGINE lamotrigine TABLET;ORAL 078525-002 Jan 27, 2009 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Roxane LAMOTRIGINE lamotrigine TABLET;ORAL 077392-004 Jan 27, 2009 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amring Pharms LAMOTRIGINE lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 214124-004 Feb 3, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.